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STRATEGIC SOLUTIONS FOR LIFE SCIENCES COMPANIES

TAKE CONTROL OF YOUR FUTUREFor life sciences innovators, today’s dynamic healthcare

environment offers tremendous opportunities, especially

given technological advancements and rapidly improving

clinical outcomes.

However, challenges to success are significant in complex and

evolving global environments:

• With revolutionary changes in healthcare delivery models,

innovators must deal with uncertainty and be ready to

adapt quickly;

• The market simply won’t accept marginal improvements—

instead, life sciences companies are challenged to transform

treatment paradigms in ways that demonstrate truly

significant clinical and/or economic value;

• Hurdles to successful innovation and commercial success

are increasing. They span shifting regulatory requirements,

tightening access, increasingly restrictive budgets, and

competitive pressures that vary significantly across

therapeutic areas and global markets;

• Achieving corporate growth and financial goals demands

accelerated commercialization of innovative products and

therapies while deriving maximum value from existing assets,

leveraging into smart adjacencies, and optimizing the value

and return on investment across the entire portfolio.

• Increased enforcement, coupled with massive fines and

penalties, can cripple any organization and only those that

invest in effective compliance programs reduce the risk of

improper behavior allowing the organization to focus on their

core values and beliefs; helping treat patients in the highest

ethical manner.

Left unresolved, any of these challenges can form roadblocks to success and can meaningfully limit future opportunities.

But handled skillfully, they can reveal new pathways to success.

AT NAVIGANT, WE COLLABORATE WITH PHARMACEUTICAL, BIOTECH, AND SPECIALTY PHARMA COMPANIES, AND MEDICAL TECHNOLOGY MANUFACTURERS TO HELP DELIVER MEASURABLE AND TRANSFORMATIVE RESULTS.

Navigant clients include 22 of the top 25 global life sciences

companies as well as many more of today’s most innovative

life sciences organizations.

Our seasoned professionals and highly skilled specialists are

located in Boston, Chicago, Minneapolis, Dallas, Los Angeles,

New York, Princeton, San Francisco, Atlanta, Berlin, India,

Shanghai, and London. With deep global relationships, we are

uniquely able to augment our in-house expertise with on-the-

ground research partners that further expand our perspectives

in target markets.

We help life sciences companies build, manage, and protect

their businesses by:

• Providing a foundation of insight to help clients grow and

innovate, develop products, and build franchises;

• Developing solutions that help clients manage strategic,

operational, and financial plans and thrive in the dynamic

healthcare environment; and

• Delivering expert advice and counsel to help protect against

competitive, market access, and regulatory risks while

proactively anticipating and preparing for future challenges.

Navigant Life Sciences solutionsWe work with clients to optimize decision-making at the

product, business unit, and enterprise level.

Product—Planning and development

Market access, pricing, and reimbursement

Product—Commercialization

Franchise and business unit strategy

Corporate strategy

Regulatory and Compliance

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Navigant teams work across the product lifecycle from portfolio

planning, clinical development, and market development through

launch and lifecycle management.

Our Life Sciences Strategy practice maintains a 360˚ view of

the pharmaceutical, biotech, and specialty pharma industries

as well as the global healthcare landscape in which life sciences

companies operate. We routinely supplement our industry

experience with broad provider, payer, and regulatory expertise

in collaboration with Navigant’s healthcare practice. We access

the perspectives of a wide variety of stakeholders to help our

clients understand all the critical aspects of the marketplace.

We provide data-driven market analysis to help medical device

and life sciences companies accelerate adoption and maximize

growth. Our proprietary Science of Market Development

methodology assesses the true barriers to broad market

adoption informed by the comprehensive analysis of failed, niche,

slow growing and wildly successful medical technologies. As a

result, companies can invest and plan accordingly to realize a

product’s true market potential and improve ROI.

Navigant product planning and development solutions

• Customer unmet needs analysis

• TPP optimization and assessment

• Patient journey mapping

• Strategic Market Assessment (SMA)

• Market entry/go-to-market strategy

• Clinical development planning/clinical trial strategy

• Product life cycle planning

• Medical affairs strategy

• Advocacy group strategy

• Advisory board support

UNPARALLELED EXPERIENCE

Navigant’s 220+ life sciences advisors bring decades of experience in market development, new product planning, and the development of innovative life sciences products. They include:

Marie Cassese brings expertise in business innovation,

profitability enhancement, evaluation of prospects for new

technologies, formulation of strategies for growth, market

entry, market development, and tactical implementation.

She has published a series of articles on integrating market

access into clinical trial design and the development of payer

evidence programs in the international biopharma journal

IN VIVO. In addition, Marie has served as a key senior executive

in several multi-hospital health systems. Most recently, she held

positions as president of an Atlantic Health System hospital

and as a corporate officer of the Atlantic Health System in

New Jersey. She also has years of experience as a cardiovascular

advanced practice nurse.

Doug Martin, MD, focuses on product, disease, and therapeutic

area strategy, new product planning, and due diligence

on behalf of senior management, pipeline marketing, and

business/corporate development teams. He has expertise in

virtually every therapeutic area. Doug began his consulting

career at McKinsey & Company. Prior to joining McKinsey,

he completed his residency in internal medicine at Brigham and

Women’s Hospital, served as a teaching fellow at Harvard Medical

School, and was elected Chief Resident at the West Roxbury VA

Hospital, one of the program’s two base hospitals.

Roger Zan joined Navigant from Novo Nordisk, where he led

a number of commercial functions and developed specialized

expertise. He brings extensive background in the pharmaceutical

and medical device industries with broad experience in product

development, launching new products, lifecycle management,

and public affairs. He has worked on a variety of projects within

primary and specialty disease areas, such as rare diseases,

cardiometabolic, immunology, and CNS.

PRODUCT—PLANNING AND DEVELOPMENT

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POWERFUL RESULTS

BREAKING INTO A CROWDED MARKET

The asthma market is crowded with therapeutic options. So, when our client developed a novel biologic therapy for the treatment of severe asthma and other indications, they needed a comprehensive product strategy to overcome the challenges associated with late market entry. Navigant drew insights from primary research, cross-functional input, and

Navigant asthma experience and expertise to develop a roadmap with clear strategies for medical affairs, market access, and marketing channels. The engagement allowed the client team to establish a roadmap for ongoing product planning, launch, and commercialization and to build broad consensus on future market perspectives and competitor expectations.

STRATEGIC MARKET ASSESSMENT

Applying the proprietary Strategic Market Assessment research and analysis framework, Navigant uncovered a multi-billion-dollar opportunity existed for a global medical device company with a new surgical robot technology. Research revealed, to date, most U.S. robotic surgeries targeted complex urology and gynecology procedures with high intraoperative conversion rates.

Navigant also identified other appropriate procedures to target, and provided an investment strategy and forecasting model to support the expansion initiative. While this investment would expand the market for all players, it made the competitive dynamics more manageable. With this new insight into the market landscape, the global company reset both its strategy and revenue growth expectations.

ADVOCACY GROUP STRATEGY

A multi-national pharma client hired Navigant to help organize its patient advocacy and outreach activities for several of its major brands in development. At that time, the activities had been disparate, one-off engagements with little coordination across the organization or with partners.

The Navigant team looked at the current state of activities, while benchmarking competitors, and then facilitated a workshop to help the client team prioritize where dollars are spent. Additionally, we tapped into experts from across Navigant’s healthcare practice, bringing clarity to the value expectations of payers and providers.

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Securing market access is integral to optimal product development, commercialization, and lifecycle planning. At Navigant, we collaborate with life sciences clients to help develop and integrate market research, analysis, and insights into clinical and commercial decision-making.

With a thorough understanding of country-level reimbursement landscapes and a broad network of key stakeholders, we are able to analyze the key dynamics and levers of market access strategy. We combine economic expertise with deep clinical expertise to identify and substantiate value drivers for products in development.

We help clients incorporate a market access mindset throughout the product development lifecycle from portfolio planning and early development decisions through market development and lifecycle management. Through stakeholder mapping, unmet needs and funding flow analysis, and value proposition optimization, we assist clients in defining and developing differentiated products through a full suite of value substantiation

and quantification solutions.

Strategy, Evaluation, and Planning

• Stakeholder mapping/funding flow analysis

• Accurate and quantifiable disease modeling


• Value proposition optimization/evidence substantiation planning

• Payer mock negotiations

• Pricing strategy (including qualitative/quantitative price finding studies)

• International price reference modeling

Go to Market and Commercialization

• Launch sequence analysis

• Billing and coding analysis and planning

• Payer policy surveillance

• Reimbursement policy development and legislative analyses

• Health economics and outcomes research (HEOR) studies and real-world evidence (RWE) generation

• Value dossiers and cost-effectiveness, and budget impact models

• Reimbursement hotlines, appeals programs, and other

reimbursement support services

PRODUCT—MARKET ACCESS, PRICING AND REIMBURSEMENT


Navigant consultants are experts at gaining access to new markets around the globe. They include:

Kuo Bianchini Tong is a managing director in the Life Sciences practice of Navigant. He works with commercial stage companies to develop comprehensive market access strategies and is known for his work with disruptive technologies that have unique form factors, novel routes of delivery, policy and market access challenges, across all settings of care. Kuo also works with companies in earlier stages of development to raise funds and ensure that product R&D and clinical activities align and support optimal pricing, reimbursement, and market access.

Dr. Ravi Degun brings more than 10 years of experience in healthcare, life sciences, and R&D with experience in academia, government research, and consulting. Ravi serves major and emerging biological, pharmaceutical, and medical device companies, governments, and the European healthcare sector, focusing on market access/pricing and reimbursement, real world data collection, resource utilization, non-interventional studies, and commercial strategy. His background spans medical research focusing on oncology, virology (HIV), and immunology.

Jacob Graham works with clients to design comprehensive market access strategies with an emphasis on optimizing patient access at a value-based price. With a deep understanding of technology assessment, health economics, coding/payment policy, pricing, and commercial strategy, Jacob has helped many med-tech and biopharmaceutical clients to ensure that R&D, clinical, and market access initiatives align with financial expectations. He has also helped clients achieve meaningful coverage and payment milestones, attain commercial success, and raise capital.

Ken Walsh brings more than 15 years of experience across the pharmaceutical industry and consulting. Ken has deep experience across a range of issues and brands within CNS, oncology, and immunology. Additionally, he actively gives presentations at international conferences across a range of market access and public policy issues. In previous role, Ken was head of pricing in GSK’s emerging markets division based in Brentford and global head of pricing and market access for Sandoz Biosimilars and Oncology injectables business unit based in Munich.

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POWERFUL RESULTS

INTERNATIONAL PRICE REFERENCING

Given the interconnectivity of price referencing, rolling out new products across different markets is tricky business for manufacturers. Most established pharmaceutical markets use pricing rules that reference products both across and within country-lines. These rules are known as “international reference pricing” (IRP) and “therapeutic reference pricing” (TRP). Understanding their impact on a global level is challenging, with each market basing pricing decisions on different legislation and mechanisms. Navigant set out to better understand the impact of IRP and TRP on the decay

of pharmaceutical drug prices and their effects on launch pricing and sequencing across multiple markets. We developed a model to quantitatively assess the impact of IRP and TRP, as well as parallel trade, on drug prices across major global markets. Outputs of the Navigant model include impact to volume, price, and revenue as well as parallel trade. Using a dynamic launch map, the model provides an optimal price and launch sequence of a given pharmaceutical product, helping manufacturers achieve maximum success.

REIMBURSEMENT OPTIMIZATION AND CUSTOMER ENGAGEMENT STRATEGY

Preparing for the launch of a new acute hospital-based treatment, our client engaged Navigant to validate their understanding of current reimbursement dynamics, explore new and innovative funding options, augment their team’s deep product knowledge with strategic and tactical expertise in detailed reimbursement processes and up-to-date approaches, and segment hospital and integrated delivery network (IDN) customers for access strategies and tactics. Navigant responded with a tailored solution that integrated the expertise of its Global Market Access Center of Excellence, Payer & Provider practice, and Healthcare Analytics team. We provided industry perspective on the policy, market, and institutional dynamics that would

directly and indirectly influence reimbursement; reviewed reimbursement options, identifying the highest probability pathways for securing optimal access and utilization; and developed action plans providing clear direction forward with a business case and an interactive dashboard linking together all supporting research to warrant future investment.

By combining landscape assessment, hospital segmentation, stakeholder mapping, and focus groups, Navigant helped the client achieve a successful launch supported by a refined value proposition and a comprehensive customer engagement strategy.

COMPREHENSIVE MARKET ACCESS PLANNING AND EXECUTION INCLUDING PAYER ENGAGE-MENT, POLICY DEVELOPMENT, AND REIMBURSEMENT SUPPORT SERVICES

In preparation of launching a new physician administered drug, Navigant was engaged to understand the economic value of treatment and whether customer and payer adoption would be affected by different approaches to product pricing.

Navigant developed a new pricing strategy and comprehensive payer, customer, and patient-centric programs to drive adoption.

Customer support programs including a reimbursement hotline and appeals program were designed and launched with market specific

requirements in mind. Patient assistance programs and other tools were created to address any market access gaps and ease patient burden. In addition, Navigant developed comprehensive billing guides and aids, and facilitated in-person and on-line training programs to ensure adequate field based support.

Navigant also lead payer engagement activities related to coverage and pricing, and worked with coding groups to ensure proper coding and payment for physician services and the client’s drug.

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Navigant product commercialization specialists help our

clients achieve the greatest possible market penetration

for their new products.

Our consultants analyze market potential and assist clients

as they forecast opportunities for new and existing products,

optimize product positioning to healthcare providers, payers, and

patients, map key decision-making stakeholders, set strategy and

roadmap, prepare for launch, and execute tactics.

We employ an evidence-based research approach to provide

insights into the patient journey and understand drivers

that influence physician decision-making. To help assess the

market landscape, our consultants use proprietary tools and

methodologies to offer insights through strategic market

assessments, geography planning, market landscape analysis,

training, and disease reports. Importantly, we reach out to internal

and external industry participants to better understand what it will

really take for our clients’ products to succeed in the real world.

In addition, Navigant supports global brand teams by establishing

revenue forecasting/modeling and launch metrics/KPIs that our

clients will align around and can rely upon..

Navigant product commercialization solutions


• Stakeholder/key opinion leader mapping

• Competitive planning/war gaming/capability benchmarking

• Product revenue forecasting

• Sales force planning

• Geography planning

• Launch excellence

• Brand plan support

• Project management/resource support

• Loss of exclusivity strategy

PRODUCT—COMMERCIALIZATION


With 220+ life sciences advisors and 3,000 healthcare specialists, Navigant brings decades of diverse industry experiences to help clients plan and launch innovative new products.

Michele Fuller joined Navigant from Alcon, the ophthalmic

division of Novartis, where she served as country business unit

head of surgery in Malaysia and as pharmaceutical franchise

head in Asia & Russia, based out of Singapore. Her experience

spans nearly 20 years of commercial operations, marketing and

sales, management consulting, and market research in the life

sciences industry. In addition to those roles, Michele built and led

a cross-franchise global marketing sciences function, including

market research, analytics, competitive intelligence,

and forecasting verticals.

Ross Meisner has nearly 30 years of experience building high

tech and medtech companies, and brings an unparalleled

understanding of medical market dynamics to Navigant. Ross’

experience spans medical technology, management consulting,

internet financial services, and the semiconductor industry.

Before joining Navigant, Ross co-founded four start-ups,

managed two international joint ventures and directed global

market development at Medtronic, where he implemented new

methods to identify untapped growth opportunities across

geographies.

Martin Trautmann partners with clients to execute large and

complex pharmaceutical projects such as product launches and

post-merger integrations, and he helps clients establish and

manage alliances, transfer products, and execute sales force

related initiatives. Over the past five years, Martin and his team

have successfully supported the launch and commercialization

of more than 15 pipeline assets and over 10 inline brands, and

he has executed in excess of 50 complex projects. He specializes

in developing and supporting highly flexible, adaptable, and

innovative biopharmaceutical organizations.

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POWERFUL RESULTS

LAUNCH EXCELLENCE

A start-up medical device company was preparing for the launch of a transformational drug delivery system in a monopolized market to enhance the care of critically ill patients.

Navigant provided in-depth qualitative and quantitative primary research on critical launch opportunities and potential hurdles, as well as competitive benchmarking to guide internal infrastructure planning. We helped define roles and core job

responsibilities, guide headcounts and reporting structures, plan the timing of hiring and onboarding, and plan device servicing and support needs. We also developed dynamic revenue forecasting based on a robust, patient-based model, informed by market analysis and access to secondary data sources. The customized readiness and commercialization roadmap guided key activities, milestones, and timing in the 18 months prior to launch.

CUSTOMER EXPERIENCE OPTIMIZATION

Faced with persistent service challenges, a large pharma client engaged Navigant to redefine its overall customer experience for a cryopreserved cell therapy, including ordering and billing, supply chain logistics, and on-site storage, handling, and use. Navigant’s highly customer-centric

approach to this project included visits to more than 40 leading centers of care across the globe. The team’s findings informed a detailed strategy and set of recommendations that the client will incorporate into future clinical programs and commercial launch plans.

PROJECT MANAGEMENT/BRAND RESOURCE SUPPORT

A specialty pharma client needed implementation support for an asset in the midst of worldwide launches. Navigant provided dedicated resources and hands-on project management.

In addition, the Navigant team organized logistical support for global launches (taking into account timing, supply, and regulatory considerations) and international reference pricing. We were then entrenched

in brand strategy and commercial readiness activities, working with several of the client’s country teams to develop launch plans, define and build the set of materials they would need to support a successful launch, and develop key account plans. Navigant’s guidance led the client to become more organized through a critical transition period, and we trained and onboarded new client team members as they were hired.

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We use objective and fact-based assessments and prioritization

of company portfolios, geographic opportunities, white space

analyses and acquisition candidates. As a result, the organization

shares a common language, common measures, and a systematic

approach. Cross-functional teams move forward collaboratively

with a mutual understanding of what success looks like and how

to achieve it.

Navigant collaborates with clients to develop winning growth

strategies at all levels of their organizations.

We help clients identify the therapeutic areas that are best suited

for their investment. Supporting business unit leadership, we

uncover promising opportunities for growth, balance risk and

return, prioritize pipeline investments that support strategic goals,

and help squeeze maximum value from de-prioritized projects.

At the corporate level, we help our clients envision and position

for sustained success. Working closely with corporate leadership,

we help identify platforms best aligned to three, five, and 10-year

growth planning, down to the specific allocation of resources and

investment, to position organizations for success.

Navigant franchise, business unit, and corporate strategy solutions

• Portfolio Management


• Business development & licensing

− Target search & prioritization

− Due diligence/revenue forecasting

(external asset assessment)

− Asset valuation & transaction support

• Franchise/BU strategy development

− Disease area landscaping

− Franchise/BU strategy

− Portfolio planning & management

• Franchise/BU commercial model

• Enterprise strategy development

− Corporate strategy & board support

− Alliance/partnership management

− Organizational excellence strategy & execution

− Digital technology strategy

− Geographic strategy

− Innovation planning


Navigant experts help clients plan long-term strategies for accelerating business unit and corporate growth. They include:

Ashwin Singhania has 12 years of consulting experience and an

extensive practice with product launch and commercialization

strategies, market access strategies, portfolio planning and

optimization, and life cycle management. Ashwin has led teams

across a variety of global client stakeholders, including brand

marketing, market access, new product planning, business

development, and medical affairs.

Joe Galatowitsch has more than 35 years of experience in

medical technology business management, marketing, market

development and consulting. He has led hundreds of medical

technology market assessments, diseases and geographies as well

as many successful market development initiatives for startup,

multinational and global organizations. The holder of two patents

and recipient of numerous awards, Joe pioneered the statistically

validated Science of Market Development methodology, which is

used by leading medtech companies around the world.

Eduardo Schur is the leader of Navigant’s Life Sciences

practice and brings more than 25 years of experience in the

pharmaceutical and biotech industries. Previously, Eduardo

was vice president of marketing for Plavix, a blockbuster brand

for Bristol-Myers Squibb. He also held multiple pharmaceutical

marketing and sales management positions with Johnson &

Johnson in the U.S. and abroad. Eduardo excels at strategic

planning, commercial assessments, and new product launch

readiness; his therapeutic areas of expertise include neurology,

cardiology, infectious diseases, gastroenterology, and women’s

healthcare. Most recently, his work has been focused on oncology

and immunology.

FRANCHISE, BUSINESS UNIT, AND CORPORATE STRATEGY

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POWERFUL RESULTS

FRANCHISE STRATEGY

A global pharmaceutical company engaged Navigant to help define their U.S. ophthalmology franchise strategy. Our team then screened more than 200 assets based on key criteria such as deal accessibility, mechanism of action, market potential, probability of technical success (PTRS), and development timeline. Through interactive working sessions with key client leaders, Navigant

helped prioritize a short list of high-potential targets. Navigant also produced a PTS-adjusted profit and loss model demonstrating the level of investment required and the timing of potential return on investment. The client team successfully aligned with senior leadership, and they will be moving forward with the implementation of the recommendations developed in partnership with Navigant.

STRATEGIC CORPORATE GROWTH

Navigant was engaged by a top healthcare company challenged to identify a new platform for promising opportunities that would not only deliver returns as a stand-alone investment but that would have a synergistic effect across its existing product lines. Navigant scanned the industry for investment opportunities and identified more than 300 potential technologies. We overlaid a rigorous set of criteria, including asset availability,

category economics, financial track record, likelihood of technical success, competitive differentiation, and strategic fit with the client’s current assets and capabilities. Ultimately, Navigant identified six investment opportunities that, when combined with existing assets, would result in multibillion dollars in projected revenue by 2020 and grow five-fold by 2025.

FLEXIBLE CAPABILITIES, STRATEGIC SUPPLIER RELATIONSHIPS

A large traditionally structured pharmaceutical company struggled to adjust to changing market dynamics and client needs. Seeking to propel commercial growth, it engaged Navigant’s commercial excellence team to work across a wide

range of strategic, operational, regulatory, and portfolio management challenges and develop an integrated insight generation platform that was faster, cheaper, and more effective than the company’s previous methodology.

With more than 150 life sciences experts and over 3,000

healthcare specialists globally, Navigant brings unparalleled

experience and expertise to the life sciences industry.

Our team includes leading experts—including many MDs and

PhDs—with deep experience in:

• Cardiology

• Critical care

• Chronic disease

• Diagnostics and Monitoring

• CNS/Neurology

• Immunology

• Infectious disease

• Oncology

• Ophthalmology

• Orthopedics

• Pulmonology

• Rare/orphan diseases

• Urology

• Vaccines

• Women’s healthcare

Our clients include the world’s leading pharmaceutical, biotech

and specialty pharma companies.

Our medical device and diagnostic clients span the life sciences

industry, including traditional global device manufacturers,

innovative device and diagnostic newcomers, and companies

pioneering digital devices and sensors, software, and apps for

data and analytics and technology-enabled services.

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Navigant consultants draw expertise from decades of hands-on industry experience. Our team includes:

Douglas Martin, MD has more than 20 years of life sciences

consulting experience. His primary focus is product, disease,

and therapeutic area strategy, commercial excellence, and

due diligence on behalf of senior management and pipeline

marketing and business/corporate development teams. He has

worked in virtually every therapeutic area and primarily serves

biopharmaceutical clients and their investors.

Peter Lang leads the Navigant’s oncology group and brings

more than 20 years of consulting and industry experience

working with pharmaceutical and medical device clients. He has

deep expertise in strategy development and strategic brand

planning, product launch, marketing, business development,

new product evaluation, and post-merger integration. Peter has

extensive knowledge across various areas including oncology,

ophthalmology, cardiovascular health, and women’s health, as

well as various medical device markets and technologies.

John Etchberger has more than 6 years of experience in

consulting specializing in commercial strategy and marketing,

including launch strategy and value proposition development, for

pharmaceutical and biotech companies. John works with clients

in the pharmaceutical and biotech industries to address critical

portfolio and product strategy issues.

Catherine Ellis works with clients from a variety of all sizes — from

global corporations to smaller, single-technology companies. With

expertise in both acute and post-acute settings, she collaborates

with clients to assess growth opportunities, develop business

and market access strategies, and provider commercial support,

including due diligence, market assessment and development,

forecasting, portfolio analysis, and competitive intelligence.

THERAPEUTIC AREA AND INDUSTRY EXPERTISE

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MANAGING COMPLEX RISKS

In the complex regulatory environment of today’s pharmaceutical,

biotech, medical device, and diagnostics industries, companies

and their counsel face an increasing number of dispute, regulatory,

compliance, and investigation issues that have the potential for

significant financial, economic, and reputational impact.

Navigant is the firm of choice when companies and their counsel

need a resource that can successfully and efficiently integrate

the skills of complex data management and analysis with the

synthesis of highly-complex healthcare transactions, rules,

regulations, data, documents and business practices to bring

meaningful value to the co-development of a dispute, regulatory,

compliance, or investigation strategy and execution.

Saul Helman, MD provides support in investigations, litigation,

and compliance integration matters involving healthcare and life

sciences companies. Applying his knowledge, secured through

working in international marketing and clinical development

for two decades, Saul has led projects involving expert witness

testimony, litigation support, compliance implementation and

assessment, and investigation support.

J. Mark Farrar, CPA, CFE, CFF advises clients in Europe, South

America, Africa, Asia, and the U.S. on complex compliance issues

including anti-bribery and anti-corruption program development,

sales and marketing compliance, economic damages, global

transparency, privacy and GDPR issues, conducting risk

assessments, assessing patient support programs, and various

auditing and monitoring assessments. Mark has served as

the Independent Review Organization for a number of life

sciences organizations and advises Boards on the creation and

development of compliance programs.

Ann Beasley, JD has extensive experience in building, managing,

and optimizing corporate compliance programs in life sciences

companies. With a deep understanding of anti-bribery and

anti-corruption, conflicts of interest, and regulatory matters,

Beasley has worked with executive management teams to ensure

that governance and oversight obligations are fulfilled and

outstanding issues are identified and addressed.

Casey Horton, CFE leads numerous risk, compliance and

operational improvement projects, both in the U.S. and in more

than 60 countries. Casey’s expertise focuses on performance

compliance assessments and investigations, and implementing

effective and sustainable compliance solutions for clients.

LIFE SCIENCES REGULATORY AND COMPLIANCE

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COMPLEX FDA REGULATORY COMPLIANCE

A major diagnostics company required assistance with ongoing recalls and interactions with the FDA, responses to FDA 483 and Warning Letter findings, identifying and remediating quality system gaps and FDA inspection preparedness. Navigant was engaged to assist and deployed multiple consultants at each site to perform a variety of functions including: quality system gap analyses; mapping existing processes and skill sets to determine best course of action for addressing gaps/redundancies based on business strategy, needs, and

risks; participation on corporate quality improvement teams; assistance with FDA readiness including identification of front and back rooms; training of employees and subject matter experts; mock inspections and the creation of tools to assist with an inspection; and project management for remediation activities. The company was able to successfully navigate their regulatory compliance challenges with the FDA and achieve good standing and maintain access to their diagnostics supporting patient care.

DEPARTMENT OF JUSTICE LAUNCHES ANTI-KICKBACK INVESTIGATION

A global medical device company received a subpoena related to their contractual arrangements with healthcare professionals. Outside counsel turned to Navigant to investigate the company’s arrangements and determine risk, support settlement activity and recommend actions to address risks. The Navigant team established a statistically relevant sample, analyzed extensive data sets and

quantified the potential risk and related exposure. Working with outside counsel, our recommendations provided a road map to ensuring healthcare professional arrangements were established with the appropriate controls to manage risks associated with the Anti-Kickback Statute, while maintaining healthcare professional relationships that continued to support product development and product use.

GLOBAL CAPABILITIES

Navigant’s global capabilities help clients achieve success across borders:

• Our expanding global network covers over 40 markets,

including the EU, Central & Eastern Europe, U.S., Canada,

Latin America, the Middle East, & North Africa. We serve the

Asia-Pacific region with offices in China, India, Singapore,

and South Korea.

• Our global network allows us to connect with the most

relevant stakeholders to help solve your strategic

market challenges.

• We personally manage our global network of payers, key

opinion leaders, policy makers, and leading academics.

• We speak 15 major languages fluently in-house, enabling us

to conduct stakeholder interviews in key established and

emerging markets.

• All of our staff are fully trained in best practice interview

methods, ensuring the highest quality insights are gained.

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With broad ranging expertise, including healthcare, transaction

advisory, and risk and compliance management services,

Navigant is prepared to help life sciences clients with specialized

solutions that are beyond the expertise of most consulting firms.

Here are a few samples of our specialized solutions.

HEALTHCARE

Navigant’s life sciences professionals work closely with experts

from our healthcare practice, which serves the full landscape

of payer, provider, pharmacy, and other channel customer

segments. Our clients include hospitals and other provider

institutions, accountable care organizations, academic medical

centers, physician group practices, commercial payers, public

payers (CMS, Medicaid), health plans, government agencies,

pharmacies and pharmacy benefit managers.

Navigant healthcare clients span more than 300 health systems,

including 11 of the 15 “Honor Roll Hospitals” as rated by U.S. News

& World Report and 80% of the largest health systems in the

United States as listed by Definitive Healthcare. This expertise

allows us to bring our clients a deep understanding of important

market trends and dynamics in the payer/provider universe.

VALUATIONS

We are experts in analyzing and valuing businesses, ownership

interests, and intangible assets. Our professionals also specialize

in real, personal, fee-for-service, and intellectual property

valuation studies as well as fixed asset inventory and asset

management services. Clients rely on our valuation studies and

fairness opinions to help raise capital, support mergers and

acquisitions, conduct due diligence, and support tax positions.

REGULATORY, QUALITY, AND PATIENT SAFETY

Navigant’s extensive industry experience provides U.S. and

international clients comprehensive solutions for regulatory, quality,

and patient safety issues. Our team delivers expert advisory services

to a wide array of companies in the life sciences sector — from

pharmaceutical and biologic businesses to those involved with

manufacture and distribution of medical devices, in-vitro diagnostics,

companion diagnostics, and digital/connected health technologies.

Partnering with clients to manage risks and create optimal solutions

during all phases of a product’s life cycle — from product concept

and early planning to registration with FDA, EMA and related

international agencies to post-approval compliance — we regularly

manage challenging projects to help maintain compliance with the

stringent and evolving regulatory requirements worldwide.

INTEGRATED SOLUTIONS

GOVERNANCE, RISK MANAGEMENT, AND COMPLIANCE SERVICES

The core operations of global life sciences companies are

inherently exposed to increased risk. This industry is among the

most heavily regulated in the world. We help U.S. and international

companies navigate these unparalleled challenges by providing

a full range of global compliance solutions. Our team includes a

diverse mix of individuals ranging from former chief compliance

officers from industry to veterans from government agencies

(FDA, EMA, OIG, CMS, DOJ, FBI, SEC, CIA, SFO) who have been

at the forefront of the industry for decades. Our unique, firsthand

expertise gives clients the competitive edge they need to manage

and protect their businesses. Our team provides a wide range of

proactive and reactive services that include:

• Serving as the Independent Review Organization or Board

Advisor pursuant to Corporate Integrity Agreements

• Performing 3rd party due diligence as a part of establishing a

comprehensive anti-bribery anti-corruption program

• Assessing patient assistance and support programs

• Establishing global transparency programs

• Conducting various auditing and monitoring assessments

• Performing internal investigations

• Creating and operationalizing compliance risk assessments

• Establishing compliance programs for new and emerging

companies

The services listed above only scratch the surface on the

compliance advisory services our team can provide. We are often

called upon to help solve problems that are emerging in the

industry as our experts offer out of the box problem solving and

are tailored to each organization.

INVESTIGATIONS AND LITIGATION SUPPORT

Navigant’s investigators help clients with matters involving

allegations or suspicions of potential fraud, misconduct, or

violations of regulatory requirements. Our team includes former

law enforcement professionals such as special agents from the

FBI and the criminal investigation unit of the IRS, former federal

and state prosecutors, certified public accountants, individuals

with advanced business and law degrees, certified forensic and

e-discovery professionals, and technologists with data analytics

and systems expertise. These experts also support litigation

matters with expert advisory and testimony, including both

industry insights and economic analysis.

DATA ANALYTICS, INFORMATION SECURITY, AND DATA PRIVACY

The data life sciences companies collect can be a powerful tool

to assess and manage risk. The challenge is that this data is often

spread across many disparate systems, both in-house and in the

cloud, which can be difficult to manage, aggregate and analyze

to insight. This same data may also increase the potential for

risk in any organization for privacy and cybersecurity, and life

sciences companies need to make sure their data is properly

governed and utilized. As a result, organizations must develop

policies, procedures, and documentation demonstrating global

compliance that can also be operationalized by employees — all

the while continuing to move business forward.

Navigant supports our clients through our collaborative

expertise in compliance, data management and security

from both a governance and technical level. We can help life

sciences companies develop processes to address their needs

through effective data mapping, data blending, data analytics,

dashboarding, and reporting. Our technical capabilities are a

differentiator, complementing our life sciences subject matter

experts who understand the risks and business problems facing

today’s life sciences companies and advise across the product life

cycle, including product planning, commercialization, compliance

and risk monitoring, regulatory requirements, transparency and

reporting, and complex litigation or investigations.

• Data Privacy and Security - Assessment and risk management;

Policies and procedures; Privacy program governance (HIPAA

security requirements and workforce training; Breach response

process; Patient rights issues); General data protection

regulation (GDPR)

• Data Analytics, Management, and Visualization — Risk and

business evaluation; Data Mapping, Analytics and Quantum

Analyses; Centralizing disparate systems into a single platform

to perform predictive analysis and present findings that are

easy to understand

CONTACT

To learn more about Navigant life sciences

capabilities, visit Navigant.com or contact

[email protected].

ABOUT NAVIGANT

Navigant Consulting, Inc (NYSE:NCI)

is a specialized, global, professional

services firm that helps clients take

control of their future. Navigant’s

professionals apply deep industry

knowledge, substantive technical

expertise, and an enterprising approach

to help clients build, manage, and/or

protect their business interests. With

a focus on markets and clients facing

transformational change and significant

regulatory or legal pressures, the Firm

primarily serves clients in the healthcare,

energy, and financial services industries.

Across a range of advisory, consulting,

outsourcing, and technology/analytics

services, Navigant’s practitioners bring

sharp insight that pinpoints opportunities

and delivers powerful results.

©2019 Navigant Consulting, Inc. All rights reserved. W100788

Navigant Consulting, Inc. (“Navigant”) is not a certified public accounting or audit firm. Navigant does not provide audit, attest, or public accounting services. See navigant.com/about/legal for a complete listing of private investigator licenses.

This publication is provided by Navigant for informational purposes only and does not constitute consulting services or tax or legal advice. This publication may be used only as expressly permitted by license from Navigant and may not otherwise be reproduced, recorded, photocopied, distributed, displayed, modified, extracted, accessed, or used without the express written permission of Navigant.

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